,gcp,aws,unstructured-io,llamaparse-text,llamaparse-markdown,pytesseract
What are the most common adverse reactions of Iwilfin?,"IWILFIN may cause the following common adverse reactions:
- Ear infection ([1])
- Red and swollen eyes ([1]) or conjunctivitis ([0]) (pink eye) ([1])
- Cough ([0], [1], [2])
- Diarrhoea ([0], [1])
- Sinus infection ([0], [1])
- Vomiting ([0], [1])
- Stuffy, runny, itchy nose or sneezing ([1]) (allergic rhinitis) ([0], [1], [2])
- Fever ([0], [1]) or pyrexia ([0], [2])
- Pneumonia ([0], [1])
- Skin infection ([0], [1], [3])
- Upper respiratory tract infection ([0], [1])
- Urinary tract infection ([0], [1])
- Low blood cell counts ([4])
Other side effects include hearing loss ([0], [1], [2], [3]), which in more than one patient required dose reductions. ([0], [3])","The most common adverse reactions to Iwilfin include:
- Ear infection ([1])
- Red and swollen eyes ([1]) (pink eye) ([0], [1])
- Diarrhoea ([0], [1])
- Vomiting ([0], [1], [4])
- Cough ([0], [1])
- Stuffy, runny, itchy nose or sneezing ([1]) (allergic rhinitis) ([0], [1])
- Sinus infection ([0], [1])
- Fever ([0], [1])
- Pneumonia ([0], [1])
- Skin infection ([0], [1], [2])
- Low blood cell counts ([3], [4])

In some patients, Iwilfin has also been associated with hearing loss. ([0], [1], [2])","IWILFIN can cause several adverse reactions, including low blood cell counts ([4]) and failure of the bone marrow ([4]) to make adequate platelets ([4]), red blood cells ([4]), or white blood cells. ([4])

The most common adverse reactions include:
- Hearing loss ([0], [1], [2]) (11%) ([1])
- Otitis media ([0], [1]) (10%) ([1])
- Pyrexia ([0], [1]) (7%) ([1])
- Pneumonia ([0], [1], [3]) (5%) ([1])
- Diarrhea ([0], [1], [3]) (5%) ([1])
- Cough ([0], [3])
- Sinusitis ([0], [3])
- Upper respiratory tract infection ([0], [3])
- Conjunctivitis ([0], [3])
- Vomiting ([0], [3])
- Allergic rhinitis ([0], [3])
- Decreased neutrophils ([0], [1])
- Increased ALT ([0], [1])

In some patients, permanent discontinuation of IWILFIN ([0], [2]) has been necessary due to adverse reactions, including hearing loss. ([0], [2]) Dose reductions ([0], [2]) have also been required in some cases because of adverse reactions.","IWILFIN can cause several adverse reactions, with the most common (≥5 ([0], [1])%) including:
- Hearing loss ([0], [1]) (11%) ([0])
- Otitis media ([0], [1], [2]) (10%) ([0])
- Pyrexia ([0], [1], [2]) (7%) ([0])
- Pneumonia ([0], [1], [2]) (5%) ([0])
- Diarrhoea ([0], [1], [2]) (5%) ([0])
- Cough ([1], [2])
- Sinusitis ([1], [2])
- Conjunctivitis ([1], [2])
- Vomiting ([1], [2])
- Allergic rhinitis ([1], [2])

Additionally, IWILFIN may also cause more rare adverse reactions (5% ([3])) including:
- Rash ([3])
- Extremity pain ([3])
- Alopecia ([3])
- Low blood cell counts ([4])","The most common adverse reactions to Iwilfin include:

- Hearing loss ([0], [1], [3]) (11% of patients) ([1])
- Ear infection ([0], [1], [2]) (10% of patients) ([1])
- Diarrhoea ([0], [1], [2]) (5% of patients) ([1])
- Cough ([0], [2])
- Sinusitis ([0], [2])
- Pneumonia ([0], [1], [2]) (5% of patients) ([1])
- Upper respiratory tract infection ([0], [2])
- Conjunctivitis ([0], [2])
- Vomiting ([0], [2])
- Pyrexia ([0], [1], [2]) (7% of patients) ([1])
- Allergic rhinitis ([0], [2])
- Decreased neutrophils ([0], [1]) (4.2% of patients) ([1])
- Increased ALT ([0], [1]) (11% of patients) ([1])
- Increased AST ([0], [1]) (6% of patients) ([1])
- Skin infection ([0], [2], [3])
- Urinary tract infection ([0], [2]) (5% of patients) ([1])

Other adverse reactions occurring in  <5% of patients ([4]) include rash ([4]), extremity pain ([4]), alopecia ([4]), and colitis. ([4])","The most common adverse reactions to Iwilfin include:

- Ear infection ([1])
- Red and swollen eyes ([1]), also known as pink eye ([1])
- Diarrhoea ([0], [1])
- Vomiting ([0], [1])
- Cough ([0], [1])
- Stuffy, runny, itchy nose or sneezing ([1]) (allergic rhinitis) ([0], [1])
- Sinus infection ([0], [1])
- Fever ([0], [1])
- Pneumonia ([0], [1])
- Skin infection ([0], [1])
- Upper respiratory tract infection ([0], [1])
- Urinary tract infection ([0], [1])
- Low blood cell counts ([3])

Adverse reactions occurring in more than 1 patient that required dose reductions ([0]) included hearing loss. ([0]) Permanent discontinuation ([2]) of Iwilfin due to adverse reactions occurred in 11% of patients ([2]), with hearing loss ([2], [4]) also being the most common reason for this. Other serious adverse reactions occurred in 12% of patients ([2]), including skin infection in three patients. ([2])"
,"[0]: Dose reductions of IWILFIN due to an adverse reaction occurred in 8% of patients. Adverse reactions which
required dose reductions in >1 patient included hearing loss.
The most common (≥5%) adverse reactions, including laboratory abnormalities, were otitis media, diarrhea,
cough, sinusitis, pneumonia, upper respiratory tract infection, conjunctivitis, vomiting, pyrexia, allergic rhinitis,
decreased neutrophils, increased ALT, increased AST, hearing loss, skin infection, and urinary tract infection.
[1]: worsening hearing loss.
The most common side effects of IWILFIN include:
•
ear infection
•
red and swollen eyes (pink eye)
·
cough
• diarrhea
• sinus infection
•
vomiting
•
stuffy, runny, itchy nose or sneezing (allergic rhinitis)
• fever
pneumonia
skin infection
upper respiratory tract infection
•
urinary tract infection
Reference ID: 5293147
These are not all the possible side effects of IWILFIN.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
[2]: Adverse Reactiona
Respiratory Disorders
Cough
Allergic rhinitis
General Disorders
Pyrexia
Ear and Labyrinth Disorders
Hearing loss
All Grades b,c
(%)
IWILFIN
(n=85)
Grade 3
(%)
15
0
11
0
11
1.2
7
a
Severity as defined by CTCAE Version 4.03.
b Grade 1 adverse events were not comprehensively collected in Study 3b.
© No Grade 4 or 5 events were reported.
7
d Includes colitis.
Clinically relevant adverse reactions in <5% of patients who received IWILFIN included rash, extremity pain,
and alopecia.
[3]: patient included skin infection (3 patients).
Permanent discontinuation of IWILFIN due to an adverse reaction occurred in 11% of patients. Adverse
reactions which resulted in permanent discontinuation of IWILFIN in >1 patient included hearing loss.
Dose reductions of IWILFIN due to an adverse reaction occurred in 8% of patients. Adverse reactions which
required dose reductions in >1 patient included hearing loss.
[4]: What are the possible side effects of IWILFIN?
IWILFIN may cause serious side effects, including:
•
Low blood cell counts. IWILFIN can cause low blood cell counts and failure of your bone marrow to make enough
platelets, red blood cells, or white blood cells. Your healthcare provider will monitor your blood cell counts before
starting and during treatment with IWILFIN. Tell your healthcare provider right away if you develop symptoms of low
blood cell counts, including:","[0]: Dose reductions of IWILFIN due to an adverse reaction occurred in 8% of patients. Adverse reactions which
required dose reductions in >1 patient included hearing loss.
The most common (>5%) adverse reactions, including laboratory abnormalities, were otitis media, diarrhea,
cough, sinusitis, pneumonia, upper respiratory tract infection, conjunctivitis, vomiting, pyrexia, allergic rhinitis,
decreased neutrophils, increased ALT, increased AST, hearing loss, skin infection, and urinary tract infection.
[1]: Your healthcare provider will check your hearing before you start and during treatment with IWILFIN. Some people
have needed to use hearing aids. Tell your healthcare provider right way if you get ringing in your ears or any new or
worsening hearing loss.
The most common side effects of IWILFIN include:
ear infection
red and swollen eyes (pink eye)
diarrhea
vomiting
cough
stuffy, runny, itchy nose or sneezing (allergic rhinitis)
sinus infection
fever
pneumonia
skin infection
[2]: patient included skin infection (3 patients).
Permanent discontinuation of IWILFIN due to an adverse reaction occurred in 11% of patients. Adverse
reactions which resulted in permanent discontinuation of IWILFIN in >1 patient included hearing loss.
Dose reductions of IWILFIN due to an adverse reaction occurred in 8% of patients. Adverse reactions which
required dose reductions in >1 patient included hearing loss.
[3]: IWILFIN may cause serious side effects, including:
Low blood cell counts. IWILFIN can cause low blood cell counts and failure of your bone marrow to make enough
platelets, red blood cells, or white blood cells. Your healthcare provider will monitor your blood cell counts before
starting and during treatment with IWILFIN. Tell your healthcare provider right away if you develop symptoms of low
blood cell counts, including:
fever (temperature 100.4°F or higher)
feeling unusually tired or weak
[4]: If you miss a dose of IWILFIN, take it as soon as you remember. If it is within 7 hours of your next scheduled dose, skip
the missed dose and take your next dose at your regular time.
If you vomit after taking a dose, do not take an extra dose. Take your next dose at your regular time.
What are the possible side effects of IWILFIN?
IWILFIN may cause serious side effects, including:
Low blood cell counts. IWILFIN can cause low blood cell counts and failure of your bone marrow to make enough","[0]: in permanent discontinuation of IWILFIN in >1 patient included hearing loss. Dose reductions of IWILFIN due to an adverse reaction occurred in 8% of patients. Adverse reactions which required dose reductions in >1 patient included hearing loss. The most common (≥5%) adverse reactions, including laboratory abnormalities, were otitis media, diarrhea, cough, sinusitis, pneumonia, upper respiratory tract infection, conjunctivitis, vomiting, pyrexia, allergic rhinitis, decreased neutrophils, increased ALT,
[1]: safety population, the most common (≥5%) adverse reactions were hearing loss (11%), otitis media (10%), pyrexia (7%), pneumonia (5%), and diarrhea (5%). The most common (≥2%) Grade 3 or 4 laboratory abnormalities were increased ALT (11%), increased AST (6%), decreased neutrophils (4.2%), and decreased hemoglobin (3.3%). Study 3b Reference ID: 5293147  The safety of IWILFIN was evaluated in Study 3b [see Clinical Studies (14.1)]. Eligible patients were pediatric patients with high-risk neuroblastoma (HRNB)
[2]: with known MYCN-amplification. Serious adverse reactions occurred in 12% of patients who received IWILFIN. Serious adverse reactions in >1 patient included skin infection (3 patients). Permanent discontinuation of IWILFIN due to an adverse reaction occurred in 11% of patients. Adverse reactions which resulted in permanent discontinuation of IWILFIN in >1 patient included hearing loss. Dose reductions of IWILFIN due to an adverse reaction occurred in 8% of patients. Adverse reactions which required dose
[3]: you start and during treatment with IWILFIN. Some people have needed to use hearing aids. Tell your healthcare provider right way if you get ringing in your ears or any new or worsening hearing loss. The most common side effects of IWILFIN include: • ear infection • diarrhea • cough • sinus infection • pneumonia • upper respiratory tract infection • • • • • urinary tract infection red and swollen eyes (pink eye) vomiting stuffy, runny, itchy nose or sneezing (allergic rhinitis) fever skin infection
[4]: liquid. If any crushed tablet pieces remain, mix with another small amount (about 2 tablespoons) of soft food or liquid.  What are the possible side effects of IWILFIN? IWILFIN may cause serious side effects, including: • Low blood cell counts. IWILFIN can cause low blood cell counts and failure of your bone marrow to make enough platelets, red blood cells, or white blood cells. Your healthcare provider will monitor your blood cell counts before starting and during treatment with IWILFIN. Tell your","[0]: NCT02679144). Among 360 patients who received IWILFIN, 84% were exposed for 6 months or longer and
        73% were exposed for greater than one year.                               In this pooled safety population, the most common (≥5%) adverse
        reactions were hearing loss (11%), otitis media (10%), pyrexia (7%), pneumonia (5%), and diarrhea (5%). The
        most common (≥2%) Grade 3 or 4 laboratory abnormalities were increased ALT (11%), increased AST (6%),
[1]: Dose reductions of IWILFIN due to an adverse reaction occurred in 8% of patients. Adverse reactions which
             required dose reductions in >1 patient included hearing loss.
             The most common (≥5%) adverse reactions, including laboratory abnormalities, were otitis media, diarrhea,
             cough, sinusitis, pneumonia, upper respiratory tract infection, conjunctivitis, vomiting, pyrexia, allergic rhinitis,
[2]: The most common side effects of IWILFIN include:
          •   ear infection                                                  •      red and swollen eyes (pink eye)
          •   diarrhea                                                       •      vomiting
          •   cough                                                          •      stuffy, runny, itchy nose or sneezing (allergic rhinitis)
          •   sinus infection                                                •      fever
[3]: b Grade 1 adverse events were not comprehensively collected in Study 3b.
             c No Grade 4 or 5 events were reported.
             d Includes colitis.
             Clinically relevant adverse reactions in <5% of patients who received IWILFIN included rash, extremity pain,
             and alopecia.
             Table 5 summarizes the laboratory abnormalities in Study 3b.
[4]: •    If you vomit after taking a dose, do not take an extra dose. Take your next dose at your regular time.
          What are the possible side effects of IWILFIN?
          IWILFIN may cause serious side effects, including:
          •    Low blood cell counts. IWILFIN can cause low blood cell counts and failure of your bone marrow to make enough
               platelets, red blood cells, or white blood cells. Your healthcare provider will monitor your blood cell counts before","[0]: Dose reductions of IWILFIN due to an adverse reaction occurred in 8% of patients. Adverse reactions which required dose reductions in >1 patient included hearing loss.

The most common (≥5%) adverse reactions, including laboratory abnormalities, were otitis media, diarrhea, cough, sinusitis, pneumonia, upper respiratory tract infection, conjunctivitis, vomiting, pyrexia, allergic rhinitis, decreased neutrophils, increased ALT, increased AST, hearing loss, skin infection, and urinary tract infection.
[1]: In this pooled safety population, the most common (≥5%) adverse reactions were hearing loss (11%), otitis media (10%), pyrexia (7%), pneumonia (5%), and diarrhea (5%). The most common (≥2%) Grade 3 or 4 laboratory abnormalities were increased ALT (11%), increased AST (6%), decreased neutrophils (4.2%), and decreased hemoglobin (3.3%).

Study 3b
---
## The safety of IWILFIN in Study 3b
[2]: The most common side effects of IWILFIN include:

- ear infection
- red and swollen eyes (pink eye)
- diarrhea
- vomiting
- cough
- stuffy, runny, itchy nose or sneezing (allergic rhinitis)
- sinus infection
- fever
- skin infection
- pneumonia
- upper respiratory tract infection
- urinary tract infection

Reference ID: 5293147
---
These are not all the possible side effects of IWILFIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
[3]: Serious adverse reactions occurred in 12% of patients who received IWILFIN. Serious adverse reactions in >1 patient included skin infection (3 patients).

Permanent discontinuation of IWILFIN due to an adverse reaction occurred in 11% of patients. Adverse reactions which resulted in permanent discontinuation of IWILFIN in >1 patient included hearing loss.
[4]: Severity as defined by CTCAE Version 4.03.

Grade 1 adverse events were not comprehensively collected in Study 3b.

No Grade 4 or 5 events were reported.

Includes colitis.

Clinically relevant adverse reactions in &lt;5% of patients who received IWILFIN included rash, extremity pain, and alopecia.

Table 5 summarizes the laboratory abnormalities in Study 3b.","[0]: Dose reductions of IWILFIN due to an adverse reaction occurred in 8% of patients. Adverse reactions which
required dose reductions in >1 patient included hearing loss.

The most common (=5%) adverse reactions, including laboratory abnormalities, were otitis media, diarrhea,
cough, sinusitis, pneumonia, upper respiratory tract infection, conjunctivitis, vomiting, pyrexia, allergic rhinitis,
decreased neutrophils, increased ALT, increased AST, hearing loss, skin infection, and urinary tract infection.
[1]: oo0o°0

The most common side effects of IWILFIN include:

 

e ear infection e red and swollen eyes (pink eye)

e diarrhea e vomiting

e cough e — stuffy, runny, itchy nose or sneezing (allergic rhinitis)
e sinus infection e fever

e pneumonia e — skin infection

¢ upper respiratory tract infection e urinary tract infection

 

 

Reference ID: 5293147
[2]: Serious adverse reactions occurred in 12% of patients who received IWILFIN. Serious adverse reactions in >1
patient included skin infection (3 patients).

Permanent discontinuation of IWILFIN due to an adverse reaction occurred in 11% of patients. Adverse
reactions which resulted in permanent discontinuation of [WILFIN in >1 patient included hearing loss.
[3]: What are the possible side effects of IWILFIN?

IWILFIN may cause serious side effects, including:

e Low blood cell counts. IWILFIN can cause low blood cell counts and failure of your bone marrow to make enough
platelets, red blood cells, or white blood cells. Your healthcare provider will monitor your blood cell counts before
starting and during treatment with IWILFIN. Tell your healthcare provider right away if you develop symptoms of low
blood cell counts, including:
[4]: 4 Severity as defined by CTCAE Version 4.03.

’ Grade | adverse events were not comprehensively collected in Study 3b.
© No Grade 4 or 5 events were reported.

‘Includes colitis.

Clinically relevant adverse reactions in <5% of patients who received IWILFIN included rash, extremity pain,
and alopecia.

Table 5 summarizes the laboratory abnormalities in Study 3b.

Table 5: Select Laboratory Abnormalities (=1%) in Patients with HRNB Who Received I[WILFIN in"
,,,,,,
What is the recommended dosage of Iwilfin on body surface area between 0.5 m2 and 0.75 m2?,"The recommended dosage of Iwilfin for a body surface area of between 0.5 m² and 0.75 m² ([0], [2]) is 576 mg (three tablets) orally twice a day. ([0], [2]) This is based on the information provided. ([1], [3])","The recommended dosage of Iwilfin for a body surface area between ([1]) 0.5 m² ([1], [3]) and 0.75 m² ([0], [1]) is 576 mg ([0], [1], [3]) (three tablets) ([0], [1], [3]) orally twice a day. ([0], [1], [2], [3], [4])","The recommended dosage of Iwilfin for a body surface area between 0.5 m^2 and 0.75 m^2 is 384 mg ([1]) (two tablets) ([0], [1]) orally twice a day. ([0], [1])","The recommended dosage of Iwilfin for a body surface area between 0.5 m^2 and 0.75 m^2 ([1]) is 384 mg (two tablets) orally twice a day. ([1]) This dosage is based on body surface area ([0], [2], [3], [4]) (BSA) ([0], [2], [3]). The BSA dosage should be recalculated every 3 months ([0]) during treatment. Iwilfin is taken orally twice daily ([3], [4]), each dose ranging from 192 - 768 mg ([3], [4]), for a maximum of 2 years. ([2], [3], [4])","The recommended dosage of Iwilfin for a body surface area between 0.5 m2 ([0]) and 0.75 m2 ([0]) is 384 mg. ([0]) This is equivalent to two tablets orally twice a day. ([0], [1]) The dosage can be found in several studies ([0], [1], [2], [3], [4]) on the safety and effects of Iwilfin.","The recommended dosage of Iwilfin for body surface areas between 0.5 m² and 0.75 m² is 384 mg twice daily. ([0], [1]) This equates to two tablets twice daily ([3]) or 576 mg total per day. ([3]) Table 3 ([2]), which provides the recommended IWILFIN dosage modifications for the management of adverse reactions ([2]), suggests reducing the dose to 384 mg twice daily from 576 mg twice daily ([3]) in the event of adverse reactions. The minimum dose is 192 mg twice daily. ([2], [3]) If a patient is unable to tolerate ([2]) this minimum dose, IWILFIN should be permanently discontinued. ([2])"
,"[0]: Warnings and Precautions (5.1-5.3)].
2.2
Recommended Dosage of IWILFIN
The recommended IWILFIN dosage, based on body surface area (BSA), is provided in Table 1.
Recalculate the BSA dosage every 3 months during treatment with IWILFIN.
Table 1:
Recommended Dose
Body Surface Area (m²) | Dosage
>1.5
0.75 to 1.5
0.5 to 0.75
0.25 to 0.5
768 mg (four tablets) orally twice a day
576 mg (three tablets) orally twice a day
384 mg (two tablets) orally twice a day
192 mg (one tablet) orally twice a day
[1]: liver function tests. (2.1, 5.3)
Recommended dosage of IWILFIN is based on body surface area (see Table 1). (2.2)
IWILFIN is taken orally twice daily with or without food until disease
progression, unacceptable toxicity, or for a maximum of two years. (2.2)
IWILFIN tablets may be swallowed whole, chewed, or crushed and mixed with
soft food or liquid. (2.4)
--DOSAGE FORMS AND STRENGTHS
Tablets: 192 mg (3)
-CONTRAINDICATIONS--
•
.
WARNINGS AND PRECAUTIONS-
[2]: 0.75 to 1.5
0.5 to 0.75
0.25 to 0.5
768 mg (four tablets) orally twice a day
576 mg (three tablets) orally twice a day
384 mg (two tablets) orally twice a day
192 mg (one tablet) orally twice a day
2.3 Dosage Modifications for Adverse Reactions
The recommended dose reductions for adverse reactions are provided in Table 2.
Table 2: Recommended IWILFIN Dose Reductions for Toxicity Management
Current Dose
768 mg (four tablets) orally twice a day
576 mg (three tablets) orally twice a day
[3]: reflect rates observed in clinical practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to
IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface
area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who
demonstrated at least a partial response to prior multiagent, multimodality therapy for newly diagnosed or
[4]: tablet once per day. Permanently discontinue IWILFIN if the patient is unable to tolerate the minimum dose of
192 mg once daily.
Reference ID: 5293147
The recommended dosage modifications of IWILFIN for the management of adverse reactions are provided in
Table 3.
Table 3:
Recommended IWILFIN Dosage Modifications for Adverse Reactions
Adverse Reaction
Severity*
Myelosuppression [see Warnings and Precautions (5.1)]
Neutrophil count decreased
<500/mm³
Platelet count decreased
<25,000/mm³
Anemia
<8g/dL","[0]: 2.1 Recommended Testing Before Initiating IWILFIN Prior to initiating IWILFIN, perform complete blood count, liver function tests, and baseline audiogram [see Warnings and Precautions (5.1-5.3)]. 2.2 Recommended Dosage of IWILFIN The recommended IWILFIN dosage, based on body surface area (BSA), is provided in Table 1. Recalculate the BSA dosage every 3 months during treatment with IWILFIN. Table 1: Recommended Dose Body Surface Area (m ² Dosage > 1.5 768 mg (four tablets) orally twice a day 0.75 to 1.5 [1]: Recalculate the BSA dosage every 3 months during treatment with IWILFIN. Table 1: Recommended Dose Body Surface Area (m ² Dosage > 1.5 768 mg (four tablets) orally twice a day 0.75 to 1.5 576 mg (three tablets) orally twice a day 0.5 to < 0.75 384 mg (two tablets) orally twice a day 0.25 to < 0.5 192 mg (one tablet) orally twice a day 2.3 Dosage Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are provided in Table 2. Table 2: [2]: reflect rates observed in clinical practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who demonstrated at least a partial response to prior multiagent, multimodality therapy for newly diagnosed or [3]: 0.25 to < 0.5 192 mg (one tablet) orally twice a day 2.3 Dosage Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are provided in Table 2. Table 2: Recommended IWILFIN Dose Reductions for Toxicity Management Current Dose Reduced Dose 768 mg (four tablets) orally twice a day 576 mg (three tablets) orally twice a day 576 mg (three tablets) orally twice a day 384 mg (two tablets) orally twice a day 384 mg (two tablets) orally twice a day [4]: patients with high-risk neuroblastoma (HRNB) who demonstrated at least a partial response to prior multiagent, multimodality therapy including induction, consolidation, and anti-GD2 immunotherapy. Patients received IWILFIN as a single agent taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years (N=85). Among","[0]: Prior to initiating IWILFIN, perform complete blood count, liver function tests, and baseline audiogram [see Warnings and Precautions (5.1-5.3)]. 2.2 Recommended Dosage of IWILFIN The recommended IWILFIN dosage, based on body surface area (BSA), is provided in Table 1. Recalculate the BSA dosage every 3 months during treatment with IWILFIN. Table 1: Recommended Dose Body Surface Area (m2) Dosage >1.5 768 mg (four tablets) orally twice a day 0.75 to 1.5 576 mg (three tablets) orally twice a day 0.5 to < [1]: during treatment with IWILFIN. Table 1: Recommended Dose Body Surface Area (m2) Dosage >1.5 768 mg (four tablets) orally twice a day 0.75 to 1.5 576 mg (three tablets) orally twice a day 0.5 to < 0.75 384 mg (two tablets) orally twice a day 0.25 to < 0.5 192 mg (one tablet) orally twice a day 2.3 Dosage Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are provided in Table 2. Table 2: Recommended IWILFIN Dose Reductions for Toxicity Management Current Dose Reduced [2]: AND PRECAUTIONS reflect exposure to IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who demonstrated at least a partial response to prior multiagent, multimodality therapy for newly diagnosed or relapsed/refractory high-risk neuroblastoma in Study 3b (n=101; NCT02395666) and Study 14 (n=259; NCT02679144). Among 360 patients who received IWILFIN, [3]: tablet once per day. Permanently discontinue IWILFIN if the patient is unable to tolerate the minimum dose of 192 mg once daily. Reference ID: 5293147 The recommended dosage modifications of IWILFIN for the management of adverse reactions are provided in Table 3. Table 3: Recommended IWILFIN Dosage Modifications for Adverse Reactions Adverse Reaction Severity* Dosage Modification Myelosuppression [see Warnings and Precautions (5.1)] Neutrophil count decreased <500/mm3 Withhold IWILFIN until recovery to [4]: consolidation, and anti-GD2 immunotherapy. Patients received IWILFIN as a single agent taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years (N=85). Among patients who received IWILFIN, 93% were exposed for 6 months or longer and 89% were exposed for greater than one year. The median age of patients who received IWILFIN was 4 years (range: 1 to 17); 59% male; 85% White, 7% Black, 1% Asian,","[0]: Warnings and Precautions (5.1-5.3)]. 2.2 Recommended Dosage of IWILFIN The recommended IWILFIN dosage, based on body surface area (BSA), is provided in Table 1. Recalculate the BSA dosage every 3 months during treatment with IWILFIN. Table 1: Recommended Dose Body Surface Area (m2) Dosage [1]: 0.5 to < 0.75 384 mg (two tablets) orally twice a day 0.25 to < 0.5 192 mg (one tablet) orally twice a day 2.3 Dosage Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are provided in Table 2. Table 2: Recommended IWILFIN Dose Reductions for Toxicity Management [2]: daily, dosage based on body surface area (BSA) until disease progression, unacceptable toxicity, or for a maximum of 2 years [see Dosage and Administration (2.1)]. Tumor assessments were performed at 3, 6, 9, 12, 18 months, completion of treatment, and as clinically indicated. Following completion of IWILFIN therapy, patients were followed for a total duration of 7 years. The major efficacy outcome measure was event free [3]: clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in clinical practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who [4]: multimodality therapy including induction, consolidation, and anti-GD2 immunotherapy. Patients received IWILFIN as a single agent taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years (N=85). Among patients who received IWILFIN, 93% were exposed for 6 months or longer and 89% were exposed for greater than one year.","[0]: The recommended IWILFIN dosage, based on body surface area (BSA), is provided in Table 1. Recalculate the BSA dosage every 3 months during treatment with IWILFIN. |Body Surface Area (m2)|Dosage| |---|---| |>1.5|768 mg (four tablets) orally twice a day| |0.75 to 1.5|576 mg (three tablets) orally twice a day| |0.5 to < 0.75|384 mg (two tablets) orally twice a day| |0.25 to < 0.5|192 mg (one tablet) orally twice a day| #### 2.3 Dosage Modifications for Adverse Reactions [1]: ### DOSAGE AND ADMINISTRATION - Prior to initiation of IWILFIN, perform baseline audiogram, complete blood count, and liver function tests. - Recommended dosage of IWILFIN is based on body surface area (see Table 1). - IWILFIN is taken orally twice daily with or without food until disease progression, unacceptable toxicity, or for a maximum of two years. - IWILFIN tablets may be swallowed whole, chewed, or crushed and mixed with soft food or liquid. ### DOSAGE FORMS AND STRENGTHS Tablets: 192 mg [2]: The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who demonstrated at least a partial response to prior multiagent, multimodality therapy for newly diagnosed or relapsed/refractory high-risk neuroblastoma in Study 3b (n=101; NCT02395666) and Study 14 (n=259; [3]: The safety of IWILFIN was evaluated in Study 3b [see Clinical Studies (14.1)]. Eligible patients were pediatric patients with high-risk neuroblastoma (HRNB) who demonstrated at least a partial response to prior multiagent, multimodality therapy including induction, consolidation, and anti-GD2 immunotherapy. Patients received IWILFIN as a single agent taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a [4]: Patients received IWILFIN as a single agent taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years (N=85). Among patients who received IWILFIN, 93% were exposed for 6 months or longer and 89% were exposed for greater than one year.","[0]: IWILFIN as a single agent taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years (N=85). Among patients who received IWILFIN, 93% were exposed for 6 months or longer and 89% were exposed for greater than one year. [1]: The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who demonstrated at least a partial response to prior multiagent, multimodality therapy for newly diagnosed or [2]: If subsequent adverse reactions occur, continue dose reduction until reaching the minimum dose of one 192 mg tablet once per day. Permanently discontinue IWILFIN if the patient is unable to tolerate the minimum dose of 192 mg once daily. Reference ID: 5293147 The recommended dosage modifications of IWILFIN for the management of adverse reactions are provided in Table 3. Table 3: Recommended IWILFIN Dosage Modifications for Adverse Reactions Adverse Reaction Severity* Dosage Modification [3]: The recommended dose reductions for adverse reactions are provided in Table 2. Table 2: Recommended IWILFIN Dose Reductions for Toxicity Management Current Dose Reduced Dose 768 mg (four tablets) orally twice a day 576 mg (three tablets) orally twice a day 576 mg (three tablets) orally twice a day 384 mg (two tablets) orally twice a day 384 mg (two tablets) orally twice a day 192 mg (one tablet) orally twice a day 192 mg (one tablet) orally twice a day 192 mg (one tablet) orally once daily [4]: Reference ID: 5293147 F F HoN e HIN OH * HCl °H20 IWILFIN is available as a round, white to off-white tablet for oral administration. Each tablet contains 192 mg eflornithine, equivalent to 250 mg of eflornithine hydrochloride, and the following inactive ingredients: 220 mg silicified microcrystalline cellulose, 25 mg partially pregelatinized maize starch, 2.5 mg colloidal silicon dioxide, and 2.5 mg vegetable source magnesium stearate. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action"
,,,,,,
"I need a succinct summary of the compound name, indication, route of administration, and mechanism of action of Iwilfin.","Compound Name: eflornithine hydrochloride ([0], [1], [2]) (IWILFIN ([1])™)

Indication: used to reduce the risk of relapse in adult and paediatric patients with high-risk neuroblastoma (HRNB) ([1], [3]), who have responded at least partially to prior multiagent, multimodality therapy. ([1], [3], [4])

Route of Administration: IWILFIN™ tablets ([1], [3], [4]) are taken orally twice daily ([3], [4]), with doses ranging from 192 to 768 mg based on body surface area. ([3], [4])

Mechanism of Action: IWILFIN™ is an ornithine decarboxylase inhibitor. ([0], [2])
","Compound Name: eflornithine ([0], [1], [2], [3]) (IWILFIN ([0])™)

Indication: used to reduce the risk of relapse ([0], [3]) in adults ([0], [3]) and paediatric patients ([0], [3]) with high-risk neuroblastoma (HRNB) ([0], [3]) who have responded to prior therapies. ([0], [3], [4])

Route of Administration: Oral ([2], [4])

Mechanism of Action: IWILFIN is an ornithine decarboxylase inhibitor. ([1])","Compound Name: Iwilfin ([1], [2], [3], [4]) (eflornithine) ([0], [2], [3], [4])

Indication: Iwilfin is indicated to reduce the risk of relapse ([1], [3]) in adult and paediatric patients ([1], [3]) with high-risk neuroblastoma (HRNB) ([1], [3]), who have responded to prior anti-GD2 ([1]) immunotherapy ([1], [4]) and multi-modality therapy. ([1])

Route of Administration: Oral ([0], [3])

Mechanism of Action: Iwilfin is an ornithine decarboxylase inhibitor. ([1], [2], [3], [4])","Compound Name: IWILFIN ([2], [3]) (eflornithine) ([3])

Indication: IWILFIN is used to reduce the risk of relapse ([1], [2], [3]) in adult and paediatric patients ([1], [2], [3]) with high-risk neuroblastoma (HRNB) ([1], [2], [3]), who have responded at least partially to certain prior therapies. ([2], [3])

Route of Administration: IWILFIN is administered as a tablet. ([2])

Mechanism of Action: IWILFIN is an ornithine decarboxylase inhibitor. ([0], [1], [4])","Compound Name: IWILFIN ([1], [2]) (eflornithine) ([1])

Indication: IWILFIN is indicated to reduce the risk of relapse ([1], [2]) in adult and paediatric patients ([1], [2]) with high-risk neuroblastoma (HRNB) ([1], [2]), who have responded at least partially ([1], [2], [3]) to prior anti-GD2 immunotherapy ([1], [2]) and multiagent, multimodality therapy. ([1], [2], [3])

Route of Administration: Oral ([0], [1], [3], [4])

Mechanism of Action: IWILFIN acts as an ornithine decarboxylase inhibitor. ([1])","Compound Name: IWILFIN™ ([0], [2]) (eflornithine) ([0], [2])

Indication: IWILFIN is indicated to reduce the risk of relapse ([0], [2]) in adult and paediatric patients ([0], [2]) with high-risk neuroblastoma (HRNB) ([0], [2]), who have responded positively to prior anti-GD2 immunotherapy and multiagent, multimodality therapy. ([0], [2], [4])

Route of Administration: IWILFIN is administered orally ([0], [1], [3], [4]), in the form of a tablet. ([1])
 
Mechanism of Action: IWILFIN acts as an ornithine decarboxylase inhibitor. ([0])"
,"[0]: [see Indications and Usage (1)].
11
DESCRIPTION
IWILFIN is an ornithine decarboxylase inhibitor. The chemical name of eflornithine hydrochloride is 2,5-
diamino-2-(difluoromethyl) pentanoic acid hydrochloride hydrate with a molecular formula of
C6H12F2N2O2 HCl•H₂O. Its molecular weight is 236.65g/mol for the salt and hydrate form and 182.17 g/mol for
the anhydrous free base form. Eflornithine hydrochloride is a white to off-white powder, freely soluble in water
[1]: HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
IWILFIN™ safely and effectively. See full prescribing information for
IWILFIN.
IWILFIN™ (eflornithine) tablets, for oral use
Initial U.S. Approval: 2023
-INDICATIONS AND USAGE-
IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of
relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who
have demonstrated at least a partial response to prior multiagent,
[2]: evidence from adequate and well-controlled studies in pediatric patients with a median age of 4 years (range: 1
to 17) [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.1)].
The safety and effectiveness of IWILFIN have not been established in pediatric patients for other indications
[see Indications and Usage (1)].
11
DESCRIPTION
IWILFIN is an ornithine decarboxylase inhibitor. The chemical name of eflornithine hydrochloride is 2,5-
[3]: patients with high-risk neuroblastoma (HRNB) who demonstrated at least a partial response to prior multiagent,
multimodality therapy including induction, consolidation, and anti-GD2 immunotherapy. Patients received
IWILFIN as a single agent taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface
area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years (N=85). Among
[4]: reflect rates observed in clinical practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to
IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface
area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who
demonstrated at least a partial response to prior multiagent, multimodality therapy for newly diagnosed or","[0]: IWILFIN™ (I-WILL-fin)
(eflornithine)
tablets
What is IWILFIN?
IWILFIN is a prescription medicine used to reduce the risk of relapse in adults and children with high-risk neuroblastoma
(HRNB) who have had at least a partial response to certain prior therapies.
Before you take IWILFIN, tell your healthcare provider about all of your medical conditions, including if you:
have hearing problems
are pregnant or plan to become pregnant. IWILFIN can harm your unborn baby. Tell your healthcare provider right
[1]: The safety and effectiveness of IWILFIN have not been established in pediatric patients for other indications
[see Indications and Usage (1)].
11
DESCRIPTION
IWILFIN is an ornithine decarboxylase inhibitor. The chemical name of eflornithine hydrochloride is 2,5-
diamino-2-(difluoromethyl) pentanoic acid hydrochloride hydrate with a molecular formula of
C6H12F2N2O2CH2O. Its molecular weight is 236.65g/mol for the salt and hydrate form and 182.17 g/mol for
[2]: F
O
H2N
H2N
OH
HCI
H2O
IWILFIN is available as a round, white to off-white tablet for oral administration. Each tablet contains 192 mg
eflornithine, equivalent to 250 mg of eflornithine hydrochloride, and the following inactive ingredients: 220 mg
silicified microcrystalline cellulose, 25 mg partially pregelatinized maize starch, 2.5 mg colloidal silicon
dioxide, and 2.5 mg vegetable source magnesium stearate.
12
CLINICAL PHARMACOLOGY
12.1
Mechanism of Action
[3]: 1
INDICATIONS AND USAGE
IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk
neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality
therapy including anti-GD2 immunotherapy.
2
DOSAGE AND ADMINISTRATION
2.1
Recommended Testing Before Initiating IWILFIN
Prior to initiating IWILFIN, perform complete blood count, liver function tests, and baseline audiogram [see
Warnings and Precautions (5.1-5.3)].
[4]: reflect rates observed in clinical practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to
IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface
area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who
demonstrated at least a partial response to prior multiagent, multimodality therapy for newly diagnosed or","[0]: is: Reference ID: 5293147  IWILFIN is available as a round, white to off-white tablet for oral administration. Each tablet contains 192 mg eflornithine, equivalent to 250 mg of eflornithine hydrochloride, and the following inactive ingredients: 220 mg silicified microcrystalline cellulose, 25 mg partially pregelatinized maize starch, 2.5 mg colloidal silicon dioxide, and 2.5 mg vegetable source magnesium stearate. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Eflornithine is an irreversible inhibitor
[1]: IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. (1) ------------------------DOSAGE AND ADMINISTRATION---------------------- • Prior to initiation of IWILFIN, perform baseline audiogram, complete blood count, and liver function tests. (2.1, 5.3) Recommended dosage of IWILFIN
[2]: not been established in pediatric patients for other indications [see Indications and Usage (1)]. 11 DESCRIPTION IWILFIN is an ornithine decarboxylase inhibitor. The chemical name of eflornithine hydrochloride is 2,5- diamino-2-(difluoromethyl) pentanoic acid hydrochloride hydrate with a molecular formula of C6H12F2N2O2•HCl•H2O. Its molecular weight is 236.65g/mol for the salt and hydrate form and 182.17 g/mol for the anhydrous free base form. Eflornithine hydrochloride is a white to off-white powder,
[3]: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use IWILFIN™ safely and effectively. See full prescribing information for IWILFIN. IWILFIN™ (eflornithine) tablets, for oral use Initial U.S. Approval: 2023 ----------------------------INDICATIONS AND USAGE--------------------------- IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated
[4]: immunotherapy. Use of IWILFIN for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients with a median age of 4 years (range: 1 to 17) [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.1)]. The safety and effectiveness of IWILFIN have not been established in pediatric patients for other indications [see Indications and Usage (1)]. 11 DESCRIPTION IWILFIN is an ornithine decarboxylase inhibitor. The chemical name of eflornithine","[0]: The safety and effectiveness of IWILFIN have not been established in pediatric patients for other indications [see Indications and Usage (1)]. 11 DESCRIPTION IWILFIN is an ornithine decarboxylase inhibitor. The chemical name of eflornithine hydrochloride is 2,5­ diamino-2-(difluoromethyl) pentanoic acid hydrochloride hydrate with a molecular formula of [1]: IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of Withhold, reduce dose, or permanently discontinue based on severity. (5.3) relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of [2]: tablets What is IWILFIN? IWILFIN is a prescription medicine used to reduce the risk of relapse in adults and children with high-risk neuroblastoma (HRNB) who have had at least a partial response to certain prior therapies. Before you take IWILFIN, tell your healthcare provider about all of your medical conditions, including if you: [3]: Reference ID: 5293147 --- FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. 2 DOSAGE AND ADMINISTRATION [4]: ----------------------------INDICATIONS AND USAGE--------------------------­ • Hearing Loss: Monitor hearing before and during treatment with IWILFIN. IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of Withhold, reduce dose, or permanently discontinue based on severity. (5.3)","[0]: Reference ID: 5293147
---
IWILFIN is available as a round, white to off-white tablet for oral administration. Each tablet contains 192 mg eflornithine, equivalent to 250 mg of eflornithine hydrochloride, and the following inactive ingredients: 220 mg silicified microcrystalline cellulose, 25 mg partially pregelatinized maize starch, 2.5 mg colloidal silicon dioxide, and 2.5 mg vegetable source magnesium stearate.

## CLINICAL PHARMACOLOGY

### Mechanism of Action
[1]: IWILFIN™ (eflornithine) tablets, for oral use

Initial U.S. Approval: 2023

### INDICATIONS AND USAGE

IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

### DOSAGE AND ADMINISTRATION
[2]: *Sections or subsections omitted from the full prescribing information are not listed.
---
## FULL PRESCRIBING INFORMATION

### 1 INDICATIONS AND USAGE

IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

### 2 DOSAGE AND ADMINISTRATION

#### 2.1 Recommended Testing Before Initiating IWILFIN
[3]: The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who demonstrated at least a partial response to prior multiagent, multimodality therapy for newly diagnosed or relapsed/refractory high-risk neuroblastoma in Study 3b (n=101; NCT02395666) and Study 14 (n=259;
[4]: Patients received IWILFIN as a single agent taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years (N=85). Among patients who received IWILFIN, 93% were exposed for 6 months or longer and 89% were exposed for greater than one year.","[0]: IWILFIN™ (eflornithine) tablets, for oral use
Initial U.S. Approval: 2023

---INDICATIONS AND USAGE---------------- ——
IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the ris
relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who
have demonstrated at least a partial response to prior multiagent,
multimodality therapy including anti-GD2 immunotherapy. (1)

 

   

----DOSAGE AND ADMINISTRATION-------------------—--
[1]: Reference ID: 5293147
F

F

HoN e
HIN OH

* HCl °H20

IWILFIN is available as a round, white to off-white tablet for oral administration. Each tablet contains 192 mg
eflornithine, equivalent to 250 mg of eflornithine hydrochloride, and the following inactive ingredients: 220 mg
silicified microcrystalline cellulose, 25 mg partially pregelatinized maize starch, 2.5 mg colloidal silicon
dioxide, and 2.5 mg vegetable source magnesium stearate.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
[2]: Reference ID: 5293147
FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk
neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality
therapy including anti-GD2 immunotherapy.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Testing Before Initiating [WILFIN
[3]: IWILFIN as a single agent taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface
area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years (N=85). Among
patients who received IWILFIN, 93% were exposed for 6 months or longer and 89% were exposed for greater
than one year.
[4]: The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to
IWILFIN as a single agent, taken orally at doses ranging from 192 - 768 mg twice daily, based on body surface
area (BSA), until disease progression, unacceptable toxicity, or for a maximum of 2 years in patients who
demonstrated at least a partial response to prior multiagent, multimodality therapy for newly diagnosed or"